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FDA 510(k)

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

K-Number: K182690 · 2018-12-21

ApplicantGenmark Diagnostics, Incorporated
Decision Date2018-12-21
Product CodePEO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is a medical device manufactured by Genmark Diagnostics, Incorporated. It received FDA 510(k) clearance on 2018-12-21 under approval number K182690. The device is classified under product code PEO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Genmark Diagnostics, Incorporated. The 510(k) number is K182690.

When was ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel approved by the FDA?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel received FDA 510(k) clearance on 2018-12-21, under approval number K182690.

What company makes ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is manufactured by Genmark Diagnostics, Incorporated.

What is the FDA product code for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel?

The FDA product code for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel is PEO.

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Other Devices by Genmark Diagnostics, Incorporated

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Related Devices (Code: PEO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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